EFSA Technical Report on issues related to the risk assessment of active substances
On 23 April 2019, EFSA published a technical report following an expert meeting on recurrent problems encountered in the risk assessment of active substances under Regulation 1107/2009.
These topics were discussed at the General Assembly held from 14 to 16 November 2019 with experts from the various national authorities, with the aim of strengthening the harmonisation of risk assessment.
Key issues were the quality and level of detail of the evaluation reports and compliance with data requirements.
The decisions and/or opinions of the experts are presented in this technical report.
These recommendations will be applied during the EFSA peer review of active substances and should provide further clarification to applicants and rapporteur Member States on the scientific interpretation of relevant guidance documents when preparing dossiers and project/renewal evaluation reports.
The report deals with the following points:
– CRD (Chemicals Regulation Division) directive on physical and chemical properties for which experts are calling for further harmonisation. In particular, on accepted methods for physical hazards, the need for long-term storage stability data prior to authorisation in the northern zone, the need to conduct GLP studies and the inclusion of a Chemical Abstracts Service (CAS) declaration for tank mixtures.
– Physico-chemical properties of the active substance and the PPP: cases where several studies concern the same criterion, case of studies submitted by a working group, re-evaluation of previously accepted physico-chemical studies, oxidizing properties, acceptability of physico-chemical studies carried out before July 1993, i.e. excluding GLP
– Revision of guidance documents: Guides SANCO/3030/99, SANCO/3029/99 and SANCO/825/00
– Methods used for the generation of pre-approval data (Regulation (EU) 283/2013): Evaluation of the method and report on the method
– Methods for monitoring body fluids and tissues
– Evaluation of extraction efficiency in residue analysis methods
– Isomeric composition
– Relevance of impurities
– Analysis of five batches representative of the production of the active substance on a recent and current industrial scale to determine the pure active substance content, impurities, additives and each additional component other than additives, as appropriate.
– Confirmation of the identification of the analyte (active substance, relevant and significant impurities)
– LOQ for relevant and significant impurities – 5 batch analysis
– Cases of impurities detected but not quantified in some batches but quantified in others
– Specifications : Minimum purity, Identification of naturally occurring substances, Change of technical specifications upon renewal, equivalence after renewal, Co-formulants as active substances, composition of a PPP in case variants of the active substance are formed during formulation
– Microorganisms: Identification, Stability and Analytical Methods
You will find the full report at the attached link:
Outcome of the pesticides peer review meeting on general recurring issues in physical and chemical properties and analytical methods
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